MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found the main coil broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be kinked/bent, the main coil was found to be broken/fractured, the main coil was found to be stretched, and the suture was found to be broken.A coil in catheter friction functional test was unable to perform due to condition of the device, and the main coil stretch functional test was not required as the defect is confirmed.The reported main coil stretched was confirmed based on analysis.The reported coil in catheter friction could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.During analysis the main coil was found to be broken/fractured.It is probable that the main coil broken/fractured within the microcatheter due to procedural or anatomical factors during use.The main coil was found to be and stretched, and the coil delivery wire was found to be kinked bent.Based on this we can confirm that the friction that was reported in the event did occur.It can be presumed that when the friction was felt, the delivery was forced against the friction and this cause the damage to the delivery wire.The as reported ¿main coil stretched¿ and ¿coil in catheter friction¿ can be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The as analyzed ¿main coil broken/fractured during use¿, ¿main coil stretched¿, and ¿main coil suture damage¿ can be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The as analyzed ¿coil delivery wire kinked/bent¿, will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12973428
• Report Number: 3008881809-2021-00519
• Device Sequence Number: 17350875
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2024
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 22729656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 (STRYKER MANUFACTURER)
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: Asian